DrugPatentWatch Database Preview
VISTOGARD Drug Profile
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Which patents cover Vistogard, and what generic alternatives are available?
Vistogard is a drug marketed by Wellstat Therap and is included in one NDA. There are two patents protecting this drug.
This drug has one hundred and seventy-five patent family members in twenty-one countries.
The generic ingredient in VISTOGARD is uridine triacetate. There are thirty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the uridine triacetate profile page.
Summary for VISTOGARD
| International Patents: | 175 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Formulation / Manufacturing: | see details |
| DailyMed Link: | VISTOGARD at DailyMed |
Generic Entry Opportunity Date for VISTOGARD
Generic Entry Date for VISTOGARD*:
Constraining patent/regulatory exclusivity:
EMERGENCY TX OF PTS FOLLOWING A FU OR CAPECITABINE OD, OR WHO EXHIBIT EARLY-ONSET, SEVERE OR LIFE-THREATENING TOXICITY AFFECTING THE CARDIAC SYSTEM OR CNS, AND/OR EARLY-ONSET, UNUSUALLY SEVERE AR W/IN 96 HRS FOLLOWING THE END OF FU OR CAPECITABINE ADMIN. NDA:
Dosage:
GRANULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for VISTOGARD
| Ingredient-type | Pyrimidines Analogs/Derivatives |
| Drug Class | Pyrimidine Analog |
US Patents and Regulatory Information for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
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Expired US Patents for VISTOGARD
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Wellstat Therap | VISTOGARD | uridine triacetate | GRANULE;ORAL | 208159-001 | Dec 11, 2015 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
Non-Orange Book US Patents for VISTOGARD
For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration |
|---|---|---|
| 7,173,017 | Pyrimidine nucleotide precursors for treatment of systemic inflammation and inflammatory hepatitis | ➤ Try a Free Trial |
| 5,770,582 | Pharmaceutical compositions containing deoxyribonucleosides for wound healing | ➤ Try a Free Trial |
| 7,105,498 | Acylated uridine and cytidine and uses thereof | ➤ Try a Free Trial |
| 6,344,447 | Treatment of chemotherapeutic agent and antiviral agent toxicity with acylated pyrimidine nucleosides | ➤ Try a Free Trial |
| 7,307,166 | Oxpurine nucleosides and their congeners, and acyl, derivatives thereof, for improvement of hematopoiesis | ➤ Try a Free Trial |
| 6,297,222 | Acyl deoxyribonucleoside derivatives and uses thereof | ➤ Try a Free Trial |
| Patent No. | Title | Estimated Patent Expiration |
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International Patents for VISTOGARD
| Country | Document Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 9604923 | ➤ Try a Free Trial |
| South Africa | 8902928 | ➤ Try a Free Trial |
| Norway | 317199 | ➤ Try a Free Trial |
| Japan | 2003201240 | ➤ Try a Free Trial |
| Russian Federation | 2158269 | ➤ Try a Free Trial |
| Australia | 1417792 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VISTOGARD
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| 0889 | Netherlands | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATIE MET TIPIRACILHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1096 20160427 |
| 2017 00036 | Denmark | ➤ Try a Free Trial | PRODUCT NAME: TRIFLURIDINE IN COMBINATION WITH TIPIRACIL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF TIPIRACIL; REG. NO/DATE: EU/1/16/1096 20160427 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
